- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00296153
Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment
Omacor; Omega-3-Acid Ethyl Ester 90 (n-3 PUFA) and Risk Factors in HIV Infected Patients Treated With HAART, With Special Focus on Lipids
Study Overview
Status
Intervention / Treatment
Detailed Description
Results from recent studies show increasing numbers of Ischemic Heart Disease (IHD) incidents among patients on HAART treatment (Highly Active Antiviral Therapy). Three elements have received special attention:
- the immunodeficient effects of the HIV infection itself may influence the progression of arteriosclerosis
- the higher levels of risk behaviour in this group of patients (i.e. high prevalence of smokers in this group)
- The HAART treatment itself increases plasma levels of cholesterol, LDL cholesterol and triglycerides, resulting in HIV related lipodystrophy.
The cardioprotective effects of n-3 PUFAs are well established both through epidemiological studies and through small and large clinical trials. Clinical trials have shown positive effects of n-3 PUFA on plasma triglycerides, and statistically significant reductions in cardiovascular death and sudden cardiac death. Moreover n-3 PUFAs have been shown to have beneficial effects on endothelial function. Based on the above rationale it is expected that Omacor (Omega-3-acid ethyl ester 90) will have positive effects on risk factors related to Ischemic Heart Disease in HIV patients on HAART treatment.
Approximately 50 patients will be randomized to Omacor 4 grams/day or placebo. Treatment period is 12 weeks.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Aalborg, Denmark, 9100
- Aalborg Hospital, Department of Nephrology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Man/women > 18 years of age
- Documented HIV infection
- On active treatment with HAART for at least 3 months.
- Written informed consent. This implies that the patient can read and understand Danish or English
Exclusion Criteria:
- Age < 18 years
- Malign disease
- Patients assessed as not cooperative
- Patients planning to be pregnant or who are already pregnant or breast feeding.
- Patients who have been taking fish oil capsules prior to randomization. However, patients who have discontinued fish oil supplements at least 8 weeks prior to the first visit will be included
- Patients allergic to fish proteins
- Statin treatment that has been ongoing for less than three months, or a change in statin treatment dose within the last three months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
|
Omacor capsule 1000mg x 4 per day.
Duration 12 weeks
Other Names:
|
Active Comparator: 1
Omacor 1000mg x 4 / day
|
Omacor capsule 1000mg x 4 per day.
Duration 12 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The change from week 0 (baseline) to week 12 for: Plasma triglycerides
Time Frame: baseline and 12 weeks
|
baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The change from week 0 (baseline) to week 12 for: Pulse Wave Velocity, Flow medicated vasodilation
Time Frame: baseline and 12 weeks
|
baseline and 12 weeks
|
HDL-cholesterol, LDL-cholesterol, total cholesterol
Time Frame: baseline and 12 weeks
|
baseline and 12 weeks
|
Inflammatory parameters: ICAM, VCAM, sensitive CRP
Time Frame: baseline and 12 weeks
|
baseline and 12 weeks
|
Apo A, Apo B, Lp(a), fibrinogen, PAI-1 ag, vw-Factor, thrombomodulin, oxidized LDL, small dense LDL, LTB4 from stimulated granulocytes
Time Frame: baseline and 12 weeks
|
baseline and 12 weeks
|
Safety parameters
Time Frame: baseline and 12 weeks
|
baseline and 12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeppe H. Christensen, PhD, Aalborg Hospital, Department of Nephrology
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Slow Virus Diseases
- Heart Diseases
- HIV Infections
- Coronary Artery Disease
- Myocardial Ischemia
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
Other Study ID Numbers
- CTN K85 05026
- Eudract no: 2005-005135-10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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